With the increasing numbers of coronavirus (COVID-19) cases and the declaration of a global pandemic by the World Health Organization, the pharmaceutical and biotech industries are assessing how this situation may impact business operations.

Some areas that companies should consider include the following:

• Supply chain disruption, including active pharmaceutical ingredient (API) and excipient shortages
• Drug shortages and related FDA notices
• FDA inspection priority shifts
• Potential impacts on import surveillance
• Delays in FDA’s review of pending drug applications
• Possible impacts on clinical trials and necessary changes to relevant trial documents
• The impact on drug promotion and new risks created by the changing landscape

For further analysis, please see our March 13 LawFlash, Potential Impact of Coronavirus (COVID-19) on the Pharmaceutical and Biotech Industries.